Generics
Generics applications under review by EMA – August 2015
Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centralized procedure. This leads to approval of the product in all 28 European Union (EU) Member States and in Iceland, Liechtenstein and Norway. At a country level, if approval in a single EU Member State only is required, this can take place using the national procedure. However, as soon as a company seeks approval in two or more Member States, a decentralized procedure or mutual recognition procedure must be used [2].
US FDA approval for Hep B and osteoporosis generics
Indian generics maker Aurobindo Pharma (Aurobindo) has received US Food and Drug Administration (FDA) approval for two more generics from its portfolio, bringing its total abbreviated new drug application (ANDA) approvals to 210 (182 final and 28 tentative).
Generic imatinib non-inferior to Gleevec
Following the approval of four generics of imatinib in Turkey, Demirkan and co-authors from the Dokuz Eylül University in Turkey compared the efficacy of these newly approved generics with the originator product Gleevec from Novartis [1].
Alzheimer generic launched in the US
Indian generics giant Dr Reddy’s Laboratories announced on 13 July 2015 the launch of generic memantine hydrochloride tablets in dosages of 5 and 10 mg, following approval of the company’s abbreviated new drug application (ANDA) by the US Food and Drug Administration (FDA).
Generic Parkinson’s drug hits US market
Indian generics giant Dr Reddy’s Laboratories announced on 12 August 2015 that it had launched generic pramipexole dihydrochloride extended-release tablets in dosages of 0.375, 0.75, 1.5, 3 and 4.5 mg, following approval of the company’s abbreviated new drug application by the US Food and Drug Administration on 7 August 2015.
ANI Pharmaceuticals acquires 22 generics from Teva
US-based brand-name and generics manufacturer ANI Pharmaceuticals (ANI) announced on 13 July 2015 that it had acquired 22 previously marketed generics from Teva Pharmaceutical Industries (Teva).
Proposals to lessen the shortage of essential cancer drugs, generics and biosimilars in the US and the world
Essential cancer and supportive drug shortage in the US seriously affects cancer care, and increases cost pressure on the health system. These drugs are mostly off-patent generics. Collaborative efforts of FDA, pharmacists, physicians and pharmaceutical companies slightly improve this problem. However, these measures are partial. For an issue of multiple complexities there is no single magic stick that could solve it. The underlying economic issues and lack of incentives for production need to be addressed to arrive at innovative and permanent solutions for this multifactorial problem [1, 2].
Generic bivalirudin approved in US
US-based injectables and biosimilars specialist Hospira announced on 16 July 2015 the approval of its abbreviated new drug application (ANDA) for generic bivalirudin for injection by the US Food and Drug Administration (FDA).
Effect of price caps and reference pricing on generics entry
In a study carried out by Brekke and co-authors on the impact of price caps in combination with reference pricing on generics entry was investigated [1].
Actavis hit with lawsuit over generic version of weight-loss drug
US-based obesity specialist Orexigen Therapeutics (Orexigen) and its North American partner, Takeda Pharmaceuticals (Takeda), have sued Actavis (Allergan’s US generics business) over its generic version of the weight-loss drug Contrave (naltrexone/bupropion).
